Cetirza

Cetirza
SPL v1
SPL
SPL Set ID 44b22f6f-5731-4dfe-af33-4e4e54fc3af5
Route
ORAL
Published
Effective Date 2025-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetirizine (10 mg)
Inactive Ingredients
Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: G;4 Shape: rectangle Color: white Size: 9 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-04

Description

Cetirizine HCl 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Cetirizine HCl 10 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 51945-4

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine

Directions

Adults and children 12 years and over:

  • Take one tablet once daily
  • Do not take more than one tablet in 24 hours. 

Children under 12 years of age: ask a doctor

Other Information
  • do not use if blister unit is broken or torn
  • store at 59° to 86°F (15°-30°C)
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Ask Doctor If You Have
  • liver or kidney disease.
Stop Use and Ask Doctor

if an allergic reaction to this product occurs. Seek medical help right away.

When Using This Product
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Active Ingredient (in Each Caplet)

Cetirizine HCl 10 mg

Ask Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers


Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine

Directions

Adults and children 12 years and over:

  • Take one tablet once daily
  • Do not take more than one tablet in 24 hours. 

Children under 12 years of age: ask a doctor

Other Information (Other information)
  • do not use if blister unit is broken or torn
  • store at 59° to 86°F (15°-30°C)
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide

Ask Doctor If You Have (Ask doctor if you have)
  • liver or kidney disease.
Stop Use and Ask Doctor (Stop use and ask doctor)

if an allergic reaction to this product occurs. Seek medical help right away.

When Using This Product (When using this product)
  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding (If pregnant or breast feeding)

If pregnant or breast-feeding, ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Cetirizine HCl 10 mg

Ask Doctor Or Pharmacist Before Use If You Are (Ask doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)